Administrator for Information and Regulatory Affairs Executive Office of the President The subcommittee is currently reviewing recent FDA proposals that would permit the use of health-related claims or information on food labels. I have scheduled a hearing for Thursday, December 10, 1987, for the purpose of examining these proposals. In view of the major role your office played in the development of these proposals, I want to invite you or an appropriate agency representative to present testimony regarding them. The hearing will begin at 9:30 a.m. in room 2247 of the Rayburn House Office Building. Should you or another OMB official wish to avail yourself of this opportunity, please advise the subcommittee by Thursday, December 3, 1987. I thank you in advance for your cooperation in this matter and hope that the subcommittee will have the benefit of your office's testimony at its upcoming hearing. Sincerely Jed Wen TED WEISS Thank you for the invitation to testify at the hearing on the Food and Drug Administration's proposal regarding the use of health-related claims or information on food labels. Unfortunately, I will be unable to testify because of a conflicting engagement. I understand, however, that Commissioner Young will be testifying before the Subcommittee and I am confident that he will be able to respond to any questions you may have. I appreciate the invitation and regret that I will be unable to attend. Submisssion for the Record FDA's New Proposal to Permit Disease-Specific Health Claims on Food Products Thursday, December 10, 1987 House of Representatives SUBMISSION: Copy of article by Richard M. Cooper, published in The American Journal of Clinical Nutrition, Volume 44, Number 4, October 1986. The American Journal of CLINICAL NUTRITION Official Journal of The American Society heat Nutrition, Inc. ISSN 0002-9165 VOLUME 44 NUMBER 4 OCTOBER 1986 Health claims on foods-reflections on the food/ drug distinction and on the law of misbranding1 · Richard M Cooper' The Food and Drug Administration (FDA) has generally opposed and restricted the making of health claims on foods. Although there have been exceptions, the FDA has generally taken the view that specific explicit or implicit disease-related claims on a food will subject it to the new drug provisions of the law and will render it misbranded. (FDA's classification of a product as a new drug rather than as a food may be fatal for the product. New drugs, unlike foods, require premarketing approval by the agency, and the scientific requirements for ap proval are very rigorous.) This policy was formally reconsidered during the late 1970s and was re-affirmed in 1979. Over the years the policy has been enforced by numerous civil and some criminal proceedings brought on the ground that the food products involved were, by reason of the claims made in their labels, unapproved new drugs or misbranded. Despite its opposition to specific diseaserelated claims, the agency has encouraged and even required in some circumstances that certain health-related information appear on the labels of processed foods, including information about nutrient content and fats, fatty ac ids, cholesterol, and sodium. This set of developments led, in the 1970s, to the emergence of what have been called implicit health claims. As the public evinced increasing concern about obesity, cancer, cardio-vascular disease, and other ills and about their relations to diet, food labels began to proclaim their contents or lack of contents in ways intended to attract health-conscious consumers. The health claims remained implicit and unspecific because the connections between the contents of the foods and specific diseases were not articulated. Tolerance of implicit health claims was a partial and unstable answer to the central question of public policy presented by health claims on foods: how can the FDA permit food 560 labeling to contain increased information and claims about relationships between diet and health without losing the practical ability to prevent widespread dissemination of false and misleading claims? Expanded tolerance of implicit claims enabled the agency to defer coming to grips with explicit claims. But the imperatives of the marketplace drove the issue beyond FDA's control, and the central question of policy finally had to be faced. Articulation replaced implication in the fall of 1984 when Kellogg Company began a campaign promoting consumption of its All-Bran❤ cereal as a way to reduce the risk of cancer. Boxes of All-Bran® began to include the following statements: 1) “ALL-BRAN® HAS 9 GRAMS OF FIBER PER SERVING. Compare this to any other cereal. You'll find no cereal has more fiber than Kellogg's AllBran." 2) "PREVENTIVE HEALTH TIPS FROM THE NATIONAL CANCER INSTITUTE. The National Cancer Institute reports that research may suggest eating the right foods may reduce your risk of some kinds of cancer. Here are their recommendations: eat high fiber foods. A growing body of evidence says high fiber foods are important to good health.... Eat foods low in fat.... Eat fresh fruits and vegetables.... Eat a well-balanced diet and avoid being over or under weight...." The claims on the boxes were accompanied by parallel national advertising. Kellogg developed its labeling and advertising in conjunction with the National Cancer Institute. FDA did not take regulatory action against Kellogg's package labels; and, indeed, the Federal Trade Commission enthusiastically endorsed Kel 'Citations for legal cases and rulings can be obtained from Richard M Cooper, Williams & Connolly, 839 17th Street, NW, Washington, DC 20006. * in private law practice, Williams & Connolly, Washington, DC. The American Journal of Clinical Nutrition 44: OCTOBER 1986, pp 560-566. Printed in USA 1986 American Society for Clinical Nutrition |